A 3-year, multi-center study to evaluate optical coherencetomography as an outcome measure in patients with multiple sclerosis

Phase 3

Completed

• Conditions: chronic impairment of the central nervous system; multiple sclerosis; 10030064; 10007951

• Registration Number: NL-OMON37946
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Inclusion criteria for patients with MS:
1. Male and female patients aged 18-55 years inclusive
2. A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a
relapsing-remitting course
3. MS disease duration of more than one year (from diagnosis of MS) before study entry
(Screening);Inclusion criteria for participants in the reference group:
1. Male and female subjects aged 18-55 years inclusive.
2. Matched to MS patients in terms of age (±3 years),
ethnicity, gender and visual refraction (±2 diopters) with the MS patients recruited.

Exclusion Criteria

Exclusion criteria for patients with MS and reference group:
1. HIV or any other known immunodeficiency syndrome (disease or drug-induced)
2. Any ophthalmologic reason for RNFL pathology other than MS, such as optic neuropathy,
active advanced glaucoma, injury of the optic nerve or history or presence of severe
myopia based on the ophthalmologist*s clinical judgment or * history or presence of severe myopia: a. in patients who have not had refractive surgery, a refractive error of greater than 6.00 diopters b. pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma c. in patients that have had previous refractive surgery, an axial eye length of greater than 26 mm
3. Acute optic neuritis within the past 6 months before Baseline
4. Evidence of advanced, non-proliferative or proliferative diabetic retinopathy
5. Presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
6. History of a severe head trauma
7. Any of the following neurologic/psychiatric disorders:
* history of substance abuse (drug or alcohol) in the past five years or any other factor
(i.e., serious psychiatric condition) that may interfere with the subject*s ability to
cooperate and comply with the study procedures
* specific MRI findings (tumor, subdural haematoma, post-contusional changes,
territorial stroke, neurodegenerative disorders, aneurysm/arteriovenous malformation,
evidence of past macroscopic haemorrhage, or other relevant MRI findings that would
interfere with evaluation)
* progressive neurological disorder, other than MS, which may affect participation in
the study
8. Concomitant use of drugs that may directly affect retinal structure and function (e.g.
chronic systemic corticosteroids [>30 consecutive days; doses higher than Cushing
threshold e.g. prednisone 7.5mg/d], intraocular anti-angiogenic drugs [ranibizumab,
bevacizumab], intraocular steroids etc.)
9. Any medically unstable condition, progressive disease (other than MS) or other condition
that would preclude reliable participation in the study as assessed by the investigator
10. Patients unable to undergo MRI scans including gadolinium enhancement:
* reduced renal clearance (eGFR <45 ml/min)
* history of severe hypersensitivity to gadolinium-DTPA
* claustrophobia that cannot be overcome otherwise
11. Patients who have received an investigational drug or therapy within 30 days or 5 half
lives, which ever is longer, of the baseline visit.;Exclusion criteria for participants in the reference group:
1. HIV or any other known immunodeficiency syndrome (disease or drug-induced)
2. Any ophthalmologic reason for RNFL pathology, such as optic neuropathy, active
advanced glaucoma, injury of the optic nerve or history or presence of severe myopia
based on the ophthalmologist*s clinical judgment
3. Acute optic neuritis within the past 6 months before Baseline
4. Evidence of advanced, non-proliferative or proliferative diabetic retinopathy
5. Presence of retinal conditions associated with e.g. edema, subretinal fluid, cysts
6. History of a severe head trauma
7. Any of the following neurologic/psychiatric disorders:
* history of substance abuse (drug or alcohol) in the past five years or any other factor
(i.e., serious psychiatric

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary variable is the change from baseline in the RNFL thickness at Month<br /><br>36. The analyses of the primary variable will be based on the Full Analysis<br /><br>Set.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Please refer to section 9.5 of the protocol dated 25-03-2011:<br /><br>The following (para) clinical variabilities will be evaluated:<br /><br>- RNFL thickness (intra patient variability)<br /><br>- relation between change in RNFL thickness and the percentage change in brain<br /><br>volume, and the change in disability<br /><br>- disability progression<br /><br>- visual function</p><br>